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Trevena Reports Full Year 2015 Financial Results
- Achieved significant clinical and regulatory milestones in CNS and AHF programs -
- Net loss for the year of $50.5 million, or $1.15 per share -
- Company to host conference call at 7:30 AM EST today -
KING OF PRUSSIA, Pa., March 9, 2016 - Trevena, Inc. (NASDAQ: TRVN), a clinical stage pharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors (GPCRs), today announced financial results for the fourth quarter and full year ended December 31, 2015 and provided an update regarding its ongoing clinical programs.
In 2015, we made remarkable progress in building the company and advancing our pipeline, said Maxine Gowen, Ph.D., chief executive officer. Our Phase 2b data for intravenous oliceridine in moderate-to-severe post-operative pain demonstrated impressive results compared to morphine and concluded a Phase 2 program that supported a Breakthrough Therapy designation from the FDA. We also added key personnel and expertise to the company and are well positioned to advance oliceridine through Phase 3, an NDA filing, and towards commercial launch. In addition, we significantly progressed the ongoing TRV027 Phase 2 study and our earlier programs, and strengthened our balance sheet to enable furtherance of these important programs.
2015 and Recent Corporate Highlights
CNS Programs (oliceridine, TRV734, and TRV250)
Announced positive results from Phase 2b study of oliceridine (TRV130). In August, the company announced positive data from its randomized, double-blind, placebo- and active-controlled Phase 2b trial of oliceridine in moderate to severe acute pain after abdominoplasty surgery. The study achieved its primary endpoint of statistically greater pain reduction than placebo over 24 hours. In addition, in pre-specified secondary measures, oliceridine demonstrated significantly reduced nausea, vomiting, and hypoventilation events with similar levels of analgesia compared to morphine.
Initiated the Phase 3 program for oliceridine. In January 2016, the company announced the launch of the oliceridine Phase 3 clinical program with the enrollment of patients in the open-label Phase 3 ATHENA-1 study. This study will evaluate the safety and tolerability of oliceridine in patients with acute moderate-to-severe pain in a variety of surgical and medical settings.
Received Breakthrough Therapy designation for oliceridine. In February 2016, the company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the Companys lead product candidate, intravenous oliceridine, for the
The following information was filed by Trevena Inc (TRVN) on Wednesday, March 9, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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